Effective January 1, 2019, the Centers for Medicaid & Medicare Services (CMS) required plan sponsors to implement new opioid policies as part of the agency’s continued efforts to address the nation’s opioid epidemic. CMS’ three-pronged approach involves the prevention of new cases of opioid use disorder, treatment of patients who have already become dependent on or addicted to opioids, and utilization of data to aid in prevention and treatment activities.1
The new policies focus on point-of-sale safety edits as well as drug managements programs and are intended to help four Medicare Part D opioid populations: (1) new opioid users; (2) chronic opioid users; (3) users at risk for adverse reactions due to the use of concurrent medications; and (4) high risk opioid users.2
For contract year 2019, plan sponsors were required to implement four point-of-sale (POS) safety edits.2 The first of these is a seven-day supply hard edit for opioid naïve patients. Plan sponsors have implemented this safety edit by utilizing look-back logic to determine if a member is opioid naïve. For members new to the plan for which there is no claim history, pharmacists can resolve the edit with an administrative override.
Secondly, plans sponsors have implemented a soft opioid care coordination edit at 90 morphine milligram equivalents (MME).2 This edit can be triggered alone or can be set up to trigger when the member’s cumulative MME meets or exceeds 90 mg AND has a history of multiple opioid prescribers and/or opioid dispensing pharmacies. When the care coordination edit is triggered, the pharmacist will contact the prescriber to ensure that the prescriber is aware of the increased MME or multiple prescribers. The care coordination edit can be resolved at POS using Professional Pharmacy Service (PPS) codes.
Finally, the third and fourth edits are soft edits that trigger when a member has concurrent use of opioids and benzodiazepines as well as concurrent use of multiple long-acting opioids.2 These can also be resolved at POS using PPS codes.
CMS continues to give plan sponsors the option to implement a hard edit that will trigger when a patient’s cumulative opioid daily dosage meets or exceeds 200 MME.2 CMS allows plan sponsors to establish this threshold with the one caveat: it cannot be less than 200 MME. This hard edit can only be resolved through the coverage determination process.
One of the more sweeping changes for 2019 was the establishment of Drug Management Programs (DMP) by the Comprehensive Addiction and Recovery Act (CARA) legislation.3 CMS’s goal for the DMPs is to ensure appropriate care coordination for members utilizing opioids and other frequently abused drugs. Members are identified as potentially at-risk if they meet the Overutilization Monitoring System’s (OMS) mandatory criteria. Plan sponsors may also identify potentially at-risk beneficiaries by utilizing the OMS supplemental criteria. The DMP utilizes three tools to aid in better care coordination for users of opioids and other frequently abused drugs: (1) patient-specific POS claim edits, (2) pharmacy limitations that require the member to receive prescriptions for frequently abused drugs from certain pharmacies, and (3) prescriber limitations. DMP edits can only be utilized by plan sponsors with a DMP. Plan sponsors that do not have DMPs are not allowed to implement DMP edits. DMPs are currently voluntary but will become mandatory beginning January 1, 2022.
As we look to the 2020 plan year, we see that CMS continues to focus on the safe and appropriate use of opioids. The 2020 Draft Call Letter outlines the following efforts to be implemented by plan sponsors or CMS in 2020.4 Although many of these are not mandatory, CMS strongly encourages plans sponsors to adopt these strategies.
- Placement of naloxone products on generic tier(s) or the Select Care Tier, if applicable
- Naloxone co-prescribing
- Targeted education of both prescribers and members on naloxone co-prescribing
- Medically-approved non-opioid pain management as a Part C supplemental benefit
- Revised opioid overuse Star measures
- Medication Therapy Management for members at risk of adverse events due to opioid overutilization or opioid users concurrently taking potentiator drugs
We expect that the opioid strategies outlined in the draft Call Letter will remain and be finalized when the final 2020 Call Letter is published by Monday, April 1, 2019. Information regarding CMS’s opioid initiatives can be found on www.cms.gov, on the Improving Drug Utilization Review Controls in Part D page.
- CMS Roadmap to Address the Opioid Epidemic: https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Opioid-epidemic-roadmap.pdf
- Announcement of Calendar Year (CY) 2019 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter: https://www.cms.gov/MEDICARE/HEALTH-PLANS/MEDICAREADVTGSPECRATESTATS/DOWNLOADS/ANNOUNCEMENT2019.PDF
- Public Law 114-198 Comprehensive Addiction and Recovery Act of 2016: https://www.govinfo.gov/content/pkg/PLAW-114publ198/pdf/PLAW-114publ198.pdf
- Advance Notice of Methodological Changes for Calendar Year (CY) 2020 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2020 Draft Call Letter: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2020Part2.pdf